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A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1

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Trial Profile

A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Lenacapavir (Primary) ; Lenacapavir (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Gilead Sciences

Most Recent Events

  • 18 Apr 2025 Planned End Date changed from 1 Aug 2026 to 1 Dec 2026.
  • 18 Apr 2025 Planned primary completion date changed from 1 Mar 2026 to 1 Jun 2026.
  • 18 Apr 2025 Status changed from not yet recruiting to recruiting.

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